Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 30-47 are pending. Claims 1-29 have been cancelled.
Election/Restrictions
Applicant's election with traverse of Group II directed to claims 39, 40 and 45-47 in the reply filed on 18 June 2025 is acknowledged. The traversal is on the ground(s) that the designated Groups in the Office action dated 18 June 2025 include the same invention.
This argument is unpersuasive and has been addressed in the aforementioned Office action. As noted previously, the inventions of Groups I-IV do not share a special technical in light of Shi et al and thus are not linked as to form a single general inventive concept (see Office action dated 18 June 2025, p. 4, ¶ 1).Therefore, the requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 30-38 and 41-44 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification, for example on p. 13, are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g., see p. 13). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Drawings
The drawings are objected to because Figure 8 lacks letters identifying the graphs as indicated in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application.
Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency.
Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The claimed invention is directed to 39, 40 and 45-47 without significantly more. The claim(s) recite(s) a plant infected with endophyte strains of Paenibacillus sp. that provide bioprotection and/or biofertilizer properties and are thus directed to a naturally occurring product/product of nature, namely, a judicial exception (JE).
This JE is not integrated into a practical application because there are no additional claim limitations that integrate the JE into a practical application. For example, the recitation “infected” or “stably infected” or “inoculated” into an endophyte free host plant with the JE amounts to nothing more than what occurs in nature (e.g., see p. 12, ¶ 3; see also p. 17, Table 2).
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the JE.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 40, 46 and 47 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 40 is drawn to a “stably” infected plant. The metes and bounds of the claim are indefinite because the specification fails to define “stably” and because it is not clear if the claim encompasses transmitting endophyte infection from one generation to another.
Claim 46 recites the limitation “inoculated”: there is insufficient antecedent basis for this limitation as the claim from which 46 depends is directed to “infected” plants, a naturally occurring process as opposed to the introduction/inoculation of the claimed endophyte for the purpose of inducing an immune response.
Claim 47 is drawn to an endophyte and depends upon claim 46 which is drawn to a plant. Therefore, the metes and bounds of the claim are indefinite because it is unclear how claim 47 further limits the claim from which it depends because it is drawn to a product other than a plant.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 39, 40 and 45-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for making strain S02 and S25 having deposit accession numbers V21/003092 and V21/003093, respectively, does not reasonably provide enablement for making and using the exhaustive genus of P. sp. endophytes as encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
Here, the claims are broadly drawn to a plant or plant part infected with one or more endophyte strains of P. sp. that provide bioprotection and/or biofertilizer properties, a plant or seed or plant thereof derived from said plant stably infected with said endophyte, wherein the plant is a grass, grain crop or industrial crop, and wherein the inoculated plant is free of an endophyte.
Meanwhile, the specification teaches that Paenibacillus sp. bacterial strains S02 and S25 were isolated from perennial ryegrass having bioprotection and biofertilizer activity (p. 12, ¶ 3). Each strain comprised plant growth promoting (PGP) genes including nitrogen fixation (nif) genes (p. 17, Table 2).
While strain S02 significantly reduced the growth of pathogens C. graminicola and F. verticiliodes, it was unable to do so for M. nivale, the latter result which was also observed for strain S25. Similar to S02, S25 was able to reduce F. verticilloides it was unable to do so for C. graminicola (p. 22, ¶ 2 and Table 2).
Each strain comprises a diverse array of secondary metabolite gene clusters that allegedly support the bioprotection niche (p. 23, lines 29-30). When barley seedlings were submerged in bacterial cultures of S02 or S25 different transcriptome profiles from the seedlings were produced (p. 32, penultimate ¶).
However, the specification fails to provide guidance for making and/or using the vast genus of plants infected with any conceivable endophyte species having any imaginable bioprotection and/or biofertilizer trait as broadly encompassed by the claims.
Moreover, the specification fails to provide working examples representative of the genus of plants infected with any conceivable endophyte species having any imaginable bioprotection and/or biofertilizer trait as broadly encompassed by the claims.
This guidance is paramount because the specification on page 3 defines "bioprotection and/or biofertilizer” as:
the endophyte that possess genetic and/or metabolic characteristics that result in a beneficial phenotype in a plant harboring, or otherwise associated with, the endophyte. Such beneficial properties include improved resistance to pests and/or diseases, improved tolerance to water and/or nutrient stress, enhanced biotic stress tolerance, enhanced drought tolerance, enhanced water use efficiency, reduced toxicity and enhanced vigour in the plant with which the endophyte is associated, relative to an organism not harbouring the endophyte or harbouring a control endophyte such as standard toxic (ST) endophyte
In the instant matter, while the specification only teaches that S20 or S25 confer resistance to specific fungi in a specific plant species, the specification fails to teach which endophytes from the broad genus as claimed, in fact, confer virtually any conceivable beneficial property to the equally broad genus of plant species as encompassed by the claims.
Therefore, in light of the breadth of the claims, the working examples and lack therefore, the state of the art which fails to teach that P. sp. confers traits as broadly claimed and the failure of the specification to provide guidance for identifying said endophytes with the traits as claimed, the skilled practitioner would resort to trial and error experimentation which is tantamount to impermissible undue experimentation.
Claims 39, 40 and 45-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claims 39, 40 and 45-47 are drawn to a plant or plant part infected with one or more endophyte strains of P. sp. that provide bioprotection and/or biofertilizer properties, a plant or seed or plant thereof derived from said plant stably infected with said endophyte, wherein the plant is a grass, grain crop or industrial crop, and wherein the inoculated plant is free of an endophyte.
The specification describes that Paenibacillus sp. bacterial strains S02 and S25 were isolated from perennial ryegrass having bioprotection and biofertilizer activity (p. 12, ¶ 3). Each strain comprised plant growth promoting (PGP) genes including nitrogen fixation (nif) genes (p. 17, Table 2).
While strain S02 significantly reduced the growth of pathogens C. graminicola and F. verticiliodes, it was unable to do so for M. nivale, the latter result which was also observed for strain S25. Similar to S02, S25 was able to reduce F. verticilloides it was unable to do so for C. graminicola (p. 22, ¶ 2 and Table 2).
Each strain comprises a diverse array of secondary metabolite gene clusters that allegedly support the bioprotection niche (p. 23, lines 29-30). When barley seedlings were submerged in bacterial cultures of S02 or S25 different transcriptome profiles from the seedlings were produced (p. 32, penultimate ¶).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Here, the specification fails to adequately describe the vast genus of plants infected with any conceivable endophyte species having any imaginable bioprotection and/or biofertilizer trait as broadly encompassed by the claims.
Moreover, the specification fails to describe working examples representative of the genus of plants infected with any conceivable endophyte species having any imaginable bioprotection and/or biofertilizer trait as broadly encompassed by the claims.
This description is paramount because the specification on page 3 defines "bioprotection and/or biofertilizer” as:
the endophyte that possess genetic and/or metabolic characteristics that result in a beneficial phenotype in a plant harboring, or otherwise associated with, the endophyte. Such beneficial properties include improved resistance to pests and/or diseases, improved tolerance to water and/or nutrient stress, enhanced biotic stress tolerance, enhanced drought tolerance, enhanced water use efficiency, reduced toxicity and enhanced vigour in the plant with which the endophyte is associated, relative to an organism not harbouring the endophyte or harbouring a control endophyte such as standard toxic (ST) endophyte
In the instant matter, while the specification only describes that S20 or S25 confer resistance to specific fungi in a specific plant species, the specification fails to describe which endophytes from the broad genus as claimed, in fact, confer virtually any conceivable beneficial property to the equally broad genus of plant species as encompassed by the claims.
Therefore, in light of the breadth of the claims, the working examples and lack therefore, the state of the art which fails to describe that P. sp. confers traits as broadly claimed and the failure of the specification to a representative number of species of endophytes with the traits as claimed, the skilled practitioner would not be of the opinion that Applicant possesses P. sp or plants infected with said endophyte as broadly claimed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 39, 40, 45 and 46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khan et al (2008, Biosource Technology, 99, 3016-3023).
Instant claims 39, 40, 45 and 46 are drawn to a plant or plant part infected with one or more endophyte strains of Paenibacillus sp. that provide bioprotection and/or biofertilizer properties, a plant or seed or plant thereof derived from said plant stably infected with said endophyte, wherein the plant is an industrial crop, and wherein the inoculated plant is free of an endophyte. Paenibicillus sp. includes P. polymyxa (e.g., see p. 2, ¶ 2)
Khan et al disclose application of bacterial suspensions of P. polymyxa GBR-1 to inoculate tomato plants (i.e., an industrial crop) into potted soil reduced root galling by root-knot nematode (see Abstract; see also p. 3017, col. 2, last ¶; see Figure 4).
Therefore, a plant or plant part infected with one or more endophyte strains of P. sp. that provide bioprotection and/or biofertilizer properties, a plant or seed or plant thereof derived from said plant stably infected with said endophyte, wherein the plant is an industrial crop, and wherein the inoculated plant is free of an endophyte is anticipated by Khan et al.
Claim(s) 39, 40 and 45-47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (2019, Frontiers in Microbiology, 10:1-18).
Instant claims 39, 40, 45-47 are drawn to a plant or plant part infected with one or more endophyte strains of P. sp. that provide bioprotection and/or biofertilizer properties, a plant or seed or plant thereof derived from said plant stably infected with said endophyte, wherein the plant is wheat or maize, grain crop or industrial crop, and wherein the inoculated plant is free of an endophyte. Paenibicillus sp. includes P. polymyxa (e.g., see p. 2, ¶ 2)
Li et al disclose inoculation of wheat, maize and cucumber with the endophyte P. beijingesis and is known to promote plant growth (see Abstract; see p. 2, col. 2, ¶ 2; p. 3, col. 1, ¶ 1; see also p. 2, col. 1, last ¶).
Therefore, a plant or plant part infected with one or more endophyte strains of P. sp. that provide bioprotection and/or biofertilizer properties, a plant or seed or plant thereof derived from said plant stably infected with said endophyte, wherein the plant is wheat or maize, grain crop or industrial crop, and wherein the inoculated plant is free of an endophyte is anticipated by Li et al.
Conclusion
No claim is allowed.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662